Zadaxin (Thymalfasin) Plus Chemotherapy Shows Promise In Advanced
Melanoma
SAN MATEO, CA -- April 6, 2000 -- SciClone Pharmaceuticals announced that a
study published in the peer-reviewed journal Melanoma Research (Volume
10, Issue 2, April 2000) suggests that Zadaxin(R) (thymalfasin), SciClone's lead
immunotherapy, increases the effectiveness of chemotherapy for metastatic
malignant melanoma, the deadliest form of skin cancer and one of the most
rapidly increasing types of cancer worldwide.
In the open label pilot
Phase 2 study of 20 stage III-IV metastatic malignant melanoma patients, there
was a response rate of 50 percent to the combination therapy of Zadaxin,
dacarbazine (DTIC) and interferon. Five patients showed a complete response and
five showed a partial response. Median survival among all patients was 11.5
months, with five patients having survived for more than two years, and two
patients having survived for more than five years. No additional side effects or
toxicities were observed from the inclusion of Zadaxin. DTIC therapy
significantly depresses a patient's immune system. In the study, Zadaxin
significantly improved the patients' immune system by restoring their natural
killer (NK) cells and helper T-cells (CD4), both of which are disease fighting
white blood cells. "We believe Zadaxin immunotherapy will be a key component
of multiple drug treatments for numerous cancers, infectious diseases and immune
system disorders," said Donald R. Sellers, SciClone's President and Chief
Executive Officer. "This study, in addition to a prior pilot phase 2 metastatic
malignant melanoma study, several preclinical cancer studies, recent mechanism
of action studies and our long experience in treating hepatitis patients, all
validate that belief. We expect malignant melanoma to be a major focus of our
new U.S. cancer program." No proven life-prolonging therapy exists for
metastatic malignant melanoma, the leading cause of skin cancer death.
Approximately 44,000 new cases are diagnosed each year in the U.S. and 7,300
deaths are reported. The response rate with the current drug of choice, DTIC, is
approximately 20 percent and is usually of short duration with little impact on
survival.
Many patients with cancer and chronic infectious diseases have
an impaired immune system. Zadaxin significantly enhances the immune system's
ability to recognize and destroy cancerous and infected cells. Zadaxin may be a
key component in the growing trend toward multiple drug cocktails for cancer and
infectious diseases. Zadaxin immunotherapy is in late-stage development for
cancer and viral hepatitis worldwide. Zadaxin now is approved for marketing in
19 countries, principally for treatment of hepatitis B and hepatitis C. SciClone
has filed for Zadaxin marketing approval in 18 additional countries.
SciClone Pharmaceuticals is a global specialty pharmaceutical company that
develops and commercializes novel medicines for treating a broad range of the
world's most serious diseases. The Company has focused its current product
development and commercialization activities on cancer, hepatitis B, hepatitis
C, drug-resistant tuberculosis and cystic fibrosis. Related Links: Zadaxin (thymalfasin) and SciClone
Pharmaceuticals.
